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FDA Found Answer To Vibativ Dilemma Of Teratogenicity Vs. Microbial Resistance In REMS

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

A Risk Evaluation and Mitigation Strategy that addresses the teratogenicity of Theravance’s Vibativ enabled FDA to manage an internal disagreement that pitted the drug’s risk to the unborn against the public health need for new antibiotics.

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Although often overshadowed by the novelty of FDA’s sweeping authority in constructing Risk Evaluation and Mitigation Strategies, examination of agency review documents suggest that the FDA Amendments Act’s other safety innovation, granting FDA the ability to require (i.e., enforce) post-marketing studies, is increasingly important to the approval of NDAs with marginal data on issues of concern.

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Out Of The Shadow Of REMS: FDA Review Documents Show Emerging Importance Of Post-Marketing Requirements

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